INFORMATION FOR CONSUMERS

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Consumer Medicine Information

REQUIP

ropinirole hydrochloride 0.25, 0.5, 1, 2, or 5mg tablets

What Is In This Leaflet?

This leaflet answers some of the common questions about REQUIP tablets. It does not contain all of the available information. It does not take the place of talking to your doctor, nurse or pharmacist.

If you are helping someone else to take these tablets, please read this leaflet before you give the first tablet.

All medicines have risks and benefits. Your doctor has weighed the possible risks of you having REQUIP against the expected benefits.

If you have any concerns about REQUIP talk to your doctor, nurse or pharmacist.

Keep this leaflet with your medicine. You may need to read it again.

What is REQUIP and How Does It Work?

Parkinson's Disease is a disease of the nervous system associated with trembling of the arms and legs, stiffness and rigidity of the muscles and slowness of movement. It is caused by the progressive loss of brain cells, which produce the chemical dopamine. As the cells die, less dopamine is produced for the area of the brain that co-ordinates movement. Symptoms develop as the brain nerve cells die off and dopamine levels drop.

REQUIP belongs to a group of medicines known as dopamine agonists. Dopamine agonists work by increasing the dopamine levels in the brain. This helps to lessen the symptoms of Parkinson's Disease.

REQUIP is used to treat Parkinson's Disease.

You may be given REQUIP on its own. It may also be given with another drug used to treat Parkinson's Disease (Levodopa/L-Dopa) to improve control of your symptoms.

Before Taking REQUIP

When you must not take REQUIP

If you answer "YES" to any of the following questions and did not discuss this with your doctor, do not take these tablets. Go back to your doctor and ask what to do. You may need to be given another medicine or the dose may need to be changed:

• Are you allergic to ropinirole or any of the ingredients in REQUIP?
• Do you have severe kidney, liver or heart trouble?
• Are you breastfeeding?
• Do you suffer from a serious psychiatric disorder?
• Are you pregnant or do you think you may be?

Do not take REQUIP if the expiry date printed on the pack has passed or the packaging is torn or shows signs of tampering.

If you are not sure whether you should take REQUIP, talk to your doctor or nurse.

Tell your doctor if:

• You have has allergies to any other medicines or substances, such as dyes, foods or preservatives.
• You are taking any prescription or OTC (over-the-counter) medicines or any medicine you have bought from a supermarket or health food shop.
• You start smoking or give up smoking while taking REQUIP. Your doctor may need to adjust your dose.
• You are taking any of the following medicines:
  • Medicines to treat psychiatric conditions
  • Medicines for the lowering of blood pressure or for heart problems
  • Antibiotics
  • Medicines for asthma, bronchitis or emphysema
  • Hormone replacement therapy
  • A medicine called metoclopramide usually taken for digestive disorders
  • Other medicines for Parkinson's Disease
• You should not drink alcohol while you are taking REQUIP

REQUIP should not be taken during pregnancy or whilst breastfeeding unless the doctor tells you to. Women who are taking this medicine should use adequate precautions to avoid becoming pregnant.

REQUIP is not recommended for use in children.

Some medicines may be affected by the way other medicines work. Your doctor, nurse or pharmacist will be able to tell you what to do if REQUIP is to be given with another medicine.

Driving or using machinery:

Rarely, REQUIP can cause extreme sleepiness (somnolence) and sudden sleep onset episodes. If you start to suffer from extreme sleepiness or suddenly begin falling asleep without any apparent warning while taking REQUIP, do not drive or use machinery and avoid dangerous activities.

Taking Your Tablets

Follow the doctor's instructions about how and when you must take your medicine. When you first start taking REQUIP, the amount you take will be increased gradually. Your doctor may then increase or decrease the amount of REQUIP that you are taking to get the best effect. People usually take between 3mg and 9mg of REQUIP a day. However, some people may need to take more.

You need to take REQUIP three times a day. You should swallow the tablets whole with water. Do not chew them. You can take REQUIP with or without food. Do not take more than your doctor has prescribed.

Tell your doctor if you or your family notices that you are developing any unusual behaviours (such as an unusual urge to gamble or increased sexual urges and/or behaviours) while you are taking REQUIP. Your doctor may have to adjust or stop your dose.

Please read the pharmacist's label carefully. If you have any questions about your medicine and how to take it please ask your doctor or pharmacist.

For How Long Should You Take REQUIP?

You should keep taking REQUIP for as long as your doctor recommends. It may take a few weeks for your medicine to start to work. Do not stop taking your medicine without consulting with your doctor first.

If A Dose Is Missed

If a scheduled dose is missed, leave out that dose completely. Take your next dose at the normal time.

What If You Take Too Many Tablets (Overdose)

You must never take more tablets than your doctor recommends. Immediately telephone your doctor or Poisons Information Centre (0800 POISON or 0800 764 766) for advice, if you think you or anyone else may have taken too much REQUIP, even if there are no signs of discomfort or poisoning. Urgent medical attention may be required.

Keep telephone numbers for these places handy. If you are not sure what to do, contact your doctor or pharmacist.

Side Effects

Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well after taking REQUIP.

Any medicine can cause unwanted effects. Any effects with REQUIP are generally mild and may go away after the first few weeks of treatment.

The most common side effect is feeling sick (nauseous). Taking your tablets with meals will reduce the chance of this happening. Other side effects that may occur are vomiting, stomach ache, indigestion, drowsiness and swelling of the arms and legs. Some people may feel faint or dizzy. Some people may experience an increased sexual drive.

When REQUIP is taken with Levodopa (L-Dopa), side effects that may occur are unwanted jerky movements, hallucinations, confusion or feeling sick. If you are taking L-Dopa you may experience some uncontrollable movements (dyskinesias) when you first start taking REQUIP. Tell your doctor if this happens, as your doctor may need to adjust the dose of the medicines you are taking.

Occasionally, REQUIP may cause lowering of blood pressure or slowing of the pulse, resulting in feeling faint.

Rarely some people may experience extreme sleepiness (somnolence) or sudden sleep onset episodes (suddenly falling asleep without any apparent warning).

Very rarely allergic reactions such as red, itchy swellings on the skin (hives), swelling of the face, lips, mouth, tongue or throat may occur which may cause difficuly in swallowing or breathing, rash or intense itching.

Tell your doctor or pharmacist if these effects become troublesome or if you notice any other unwanted effects not mentioned above.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Storage

The expiry date of these tablets is printed on the foil. Do not use the medicine after this date.

Do not store above 25°C. Store in the original package. You should keep the pack in a place where children cannot see or reach it-preferably in a locked cupboard.

Never offer these tablets to anyone else. They may not be suitable for them, even if their symptoms seem the same as yours.

Product Description

What REQUIP looks like

REQUIP is a film coated, pentagonal shaped tablet containing ropinirole hydrochloride equivalent to 0.25, 0.5, 1.0, 2.0, or 5mg ropinirole. The tablets are of different colours; 0.25mg (white), 0.5mg (yellow), 1.0 mg (green), 2.0mg (pink) and 5.0mg (blue).

REQUIP Starter Pack contains a 4 week treatment schedule and is provided in a blister pack of 105 tablets (42x0.25mg, 42x0.5mg and 21x1mg tablets).

REQUIP Follow-on Pack contains a 4 week treatment schedule and is provided in a blister pack of 147 tablets (42x0.5mg, 42x1mg and 63x2mg tablets).

0.25mg tablets provided in blister pack of 210 tablets and 1.0mg, 2.0mg and 5.0mg tablets provided in bottles of 84 tablets.

Ingredients

REQUIP contains lactose, cellulose microcrystalline (E460) , croscarmellose sodium, magnesium stearate( E572) hypromellose, macrogol and titanium dioxide (E172) as excipients. The 0.25mg and 5.0mg tablets also contain polysorbate.

REQUIP does not contain gluten, sucrose, tartrazine or any other azo dyes.

All tablets (apart from the 0.25mg tablet) also contain different colouring agents according to their strengths.

The sodium content of each tablet is 0.1mg.

Further Information

REQUIP is a Prescription Only Medicine.

Distributor

Distributed In New Zealand by:
GlaxoSmithKline NZ Ltd
Private Bag 106600
Downtown Auckland

Ph: (09) 367 2900
Fax (09) 367 2910

This leaflet is copyrighted to GlaxoSmithKline and may be reproduced but not altered in any way.

Issue-6, April 2008